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news.Depomed, a specialty pharmaceutical company, has completed enrollment of Breeze 1, the first of two pivotal Phase III clinical trials in the company's registration program of DM-5689 for the non-hormonal treatment of menopausal hot flashes.
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The Phase III registration program for DM-5689 in menopausal hot flashes includes two randomized, double-blind, placebo-controlled studies of approximately 540 patients per study. The treatment duration of the Breeze 1 study is six months, with primary efficacy endpoints assessed after four and 12 weeks of stable treatment. Persistence of efficacy will be assessed at 6 months as one of the secondary endpoints.
The treatment duration in the second study, Breeze 2, is three months, also with assessment of efficacy at four and 12 weeks. Preliminary top-line data is expected to become available in the fourth quarter 2009 for both studies.
Carl Pelzel, president and CEO of Depomed, said: “We are glad that we achieved this milestone today and look forward to the results of both Breeze 1 and Breeze 2 trials in hot flashes expected later this year. We are well on plan in this important execution year for us.”